Gastric Cancer Stage IIIPhase 3NCT06939439
Using ctDNA to Guide Treatment Decisions for Stage III Gastric Cancer
A Phase 3 study testing Tislelizumab + SOX Chemotherapy and SOX Chemotherapy in people with Gastric Cancer Stage III, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The goal of this randomized, controlled phase III clinical trial is to evaluate whether combining Tislelizumab with standard SOX chemotherapy improves disease-free survival (DFS) compared to chemotherapy alone in patients with stage III gastric or gastroesophageal junction adenocarcinoma who are ctDNA-MRD positive… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer Stage III
- What is being tested?
- Tislelizumab + SOX Chemotherapy and SOX Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or Cytological Confirmation: Patients must have a confirmed diagnosis of stage III gastric or gastroesophageal junction adenocarcinoma (according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system) based on histological or cytological examination.
- Surgical Resection: Patients must have undergone D2 or more extensive lymph node dissection surgery, with available tumor tissue samples. Patients who received neoadjuvant therapy prior to surgery are excluded.
- Age: Patients must be between 18 and 75 years of age. General Condition: Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Informed Consent: Patients must be able to understand the study protocol and voluntarily participate in the study, providing written informed consent.
- Compliance: Patients must demonstrate good compliance, willingness to adhere to the treatment regimen specified in the study protocol, and ability to provide blood samples at designated time points.
- Clinical Data: Patients must have complete imaging and pathological clinical data available.
- Life Expectancy: Patients must have an expected survival of more than 3 months. Organ and Marrow Function: Patients must have adequate organ and bone marrow function.
Who cannot join
- Inability to Confirm Diagnosis: Patients who cannot be confirmed as having primary stage III gastric or gastroesophageal junction adenocarcinoma through histological or cytological examination.
- Inability to Receive Treatment: Patients who are unable to receive immune checkpoint inhibitors or SOX chemotherapy.
- Inability to Comply with Follow-up: Patients who are unable to adhere to the predetermined clinical follow-up schedule.
- Inability to Accept Study Protocol: Patients who cannot accept the treatment regimen specified in the study protocol.
- Inability to Provide Efficacy Assessment: Patients who cannot undergo or provide designated efficacy assessment methods such as CT scans.
- Autoimmune Diseases: Patients with a history of autoimmune diseases. Psychiatric or Substance Abuse Issues: Patients with a history of substance abuse that cannot be discontinued or those with psychiatric disorders, or any severe and/or uncontrolled medical conditions.
- Severe Comorbidities: Patients with any severe comorbidities that, in the investigator's judgment, may jeopardize patient safety or completion of the study.
- Pregnancy or Breastfeeding: Pregnant or breastfeeding women. Prior Neoadjuvant Therapy: Patients who received neoadjuvant therapy prior to surgery or intraoperative chemotherapy infusion.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital with Nanjing Medical Unviersity
Nanjing, Jiangsu, 210029
About this study
Official title: Circulating Tumor DNA Monitoring for Postoperative Adjuvant Therapy Decision-Making in Stage III Gastric Cancer: A Prospective, Multicenter, Randomized Controlled Phase III Clinical Trial
The goal of this randomized, controlled phase III clinical trial is to evaluate whether combining Tislelizumab with standard SOX chemotherapy improves disease-free survival (DFS) compared to chemotherapy alone in patients with stage III gastric or gastroesophageal junction adenocarcinoma who are ctDNA-MRD positive after surgery. The study will enroll 416 patients across multiple centers and will compare outcomes between two groups: patients receiving tislelizumab plus SOX chemotherapy and those receiving standard SOX chemotherapy alone. The primary questions to be addressed are whether the combination therapy improves 1-year DFS rates and whether it demonstrates an acceptable safety profile. Participants will provide tissue and blood samples for ctDNA-MRD testing, undergo postoperative adjuvant therapy (chemotherapy ± immunotherapy), and complete regular follow-up visits to monitor treatment response and safety. The trial will assess key outcomes, including DFS, overall survival (OS), and ctDNA clearance rates, to determine the clinical benefit and safety of tislelizumab in this population.
- Conditions
- Gastric Cancer Stage III
- Being tested
- Tislelizumab + SOX Chemotherapy, SOX Chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab + SOX ChemotherapyDrug
The intervention in this study involves the use of tislelizumab, a humanized IgG4 anti-PD-1 monoclonal antibody, in combination with the standard SOX chemotherapy regimen for postoperative adjuvant therapy in patients with stage III gastric or gastroesophageal junction adenocarcinoma who are ctDNA-MRD positive. Tislelizumab is administered at a dose of 200 mg intravenously every 3 weeks for a total duration of 1 year, alongside 6-8 cycles of SOX chemotherapy. The SOX regimen includes oxaliplatin (130 mg/m² intravenously every 3 weeks) and tegafur, with the dose of tegafur determined based on body surface area and administered orally twice daily for 14 days every 3 weeks.
SOX ChemotherapyDrug
The control group will receive standard SOX chemotherapy alone, serving as an active comparator to evaluate the incremental benefit of adding tislelizumab. This design ensures a rigorous comparison while maintaining alignment with current standard-of-care practices.
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab + SOX Chemotherapy | Experimental | Patients in this group will receive tislelizumab (200 mg IV every 3 weeks for 1 year) in combination with SOX chemotherapy (oxaliplatin 130 mg/m² IV every 3 weeks and tegafur based on body surface area orally twice daily for 14 days every 3 weeks). Receives: Drug: Tislelizumab + SOX Chemotherapy |
| SOX Chemotherapy Alone | Active comparator | Patients in this group will receive standard SOX chemotherapy alone (oxaliplatin 130 mg/m² IV every 3 weeks and tegafur based on body surface area orally twice daily for 14 days every 3 weeks). Receives: Drug: SOX Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival (DFS)
Measured: 1 year
Secondary outcomes (1)
overall survival(OS)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer Stage IIIStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized, controlled phase III clinical trial employs a parallel assignment model, where participants are allocated to one of two distinct treatment groups based on their postoperative ctDNA-MRD status. Patients with ctDNA-MRD positivity will be randomly assigned in a 1:1 ratio to either the trial arm (receiving tislelizumab combined with standard SOX chemotherapy) or the control arm (receiving SOX chemotherapy alone). The trial arm will receive tislelizumab administered at 200 mg intravenously every 3 weeks for 1 year, alongside 6-8 cycles of SOX chemotherapy (oxaliplatin 130 mg/m² intravenously every 3 weeks, plus tegafur based on body surface area orally twice daily for 14 days every 3 weeks). The control arm will receive SOX chemotherapy alone for 6-8 cycles. Patients with ctDNA-MRD negativity will receive standard SOX chemotherapy without randomization.
- Masking
- None (open label)
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Suzhou Medical College, The Affiliated Hospital of Xuzhou Medical University, Nanjing Gaochun People's Hospital, The Affiliated Jiangning Hospital of Nanjing Medical University
- Responsible party
- Principal investigator, Hao Xu, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939439
- Sponsor's protocol ID
- CLAYMORE
- Status last verified
- Jun 2025
- First submitted
- 15 Apr 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA Monitoring for Postoperative Adjuvant Therapy Decision-Making in Stage III Gastric Cancer: A Prospective, Multicenter, Randomized Controlled Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT06939439
- Acronym / sponsor ID
- CLAYMORE
- Conditions
- Gastric Cancer Stage III
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Suzhou Medical College, The Affiliated Hospital of Xuzhou Medical University, Nanjing Gaochun People's Hospital, The Affiliated Jiangning Hospital of Nanjing Medical University
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized, controlled phase III clinical trial is to evaluate whether combining Tislelizumab with standard SOX chemotherapy improves disease-free survival (DFS) compared to chemotherapy alone in patients with stage III gastric or gastroesophageal junction adenocarcinoma who are ctDNA-MRD positive after surgery. The study will enroll 416 patients across multiple centers and will compare outcomes between two groups: patients receiving tislelizumab plus SOX chemotherapy and those receiving standard SOX chemotherapy alone. The primary questions to be addressed are whether the combination therapy improves 1-year DFS rates and whether it demonstrates an acceptable safety profile. Participants will provide tissue and blood samples for ctDNA-MRD testing, undergo postoperative adjuvant therapy (chemotherapy ± immunotherapy), and complete regular follow-up visits to monitor treatment response and safety. The trial will assess key outcomes, including DFS, overall survival (OS), and ctDNA clearance rates, to determine the clinical benefit and safety of tislelizumab in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This randomized, controlled phase III clinical trial employs a parallel assignment model, where participants are allocated to one of two distinct treatment groups based on their postoperative ctDNA-MRD status. Patients with ctDNA-MRD positivity will be randomly assigned in a 1:1 ratio to either the trial arm (receiving tislelizumab combined with standard SOX chemotherapy) or the control arm (receiving SOX chemotherapy alone). The trial arm will receive tislelizumab administered at 200 mg intravenously every 3 weeks for 1 year, alongside 6-8 cycles of SOX chemotherapy (oxaliplatin 130 mg/m² intravenously every 3 weeks, plus tegafur based on body surface area orally twice daily for 14 days every 3 weeks). The control arm will receive SOX chemotherapy alone for 6-8 cycles. Patients with ctDNA-MRD negativity will receive standard SOX chemotherapy without randomization.
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab + SOX Chemotherapy | Experimental | Drug: Tislelizumab + SOX ChemotherapyPatients in this group will receive tislelizumab (200 mg IV every 3 weeks for 1 year) in combination with SOX chemotherapy (oxaliplatin 130 mg/m² IV every 3 weeks and tegafur based on body surface area orally twice daily for 14 days every 3 weeks). |
| SOX Chemotherapy Alone | Active comparator | Drug: SOX ChemotherapyPatients in this group will receive standard SOX chemotherapy alone (oxaliplatin 130 mg/m² IV every 3 weeks and tegafur based on body surface area orally twice daily for 14 days every 3 weeks). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histological or Cytological Confirmation: Patients must have a confirmed diagnosis of stage III gastric or gastroesophageal junction adenocarcinoma (according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system) based on histological or cytological examination.
- Surgical Resection: Patients must have undergone D2 or more extensive lymph node dissection surgery, with available tumor tissue samples. Patients who received neoadjuvant therapy prior to surgery are excluded.
- Age: Patients must be between 18 and 75 years of age. General Condition: Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Informed Consent: Patients must be able to understand the study protocol and voluntarily participate in the study, providing written informed consent.
- Compliance: Patients must demonstrate good compliance, willingness to adhere to the treatment regimen specified in the study protocol, and ability to provide blood samples at designated time points.
Key exclusion criteria (8 listed)
- Inability to Confirm Diagnosis: Patients who cannot be confirmed as having primary stage III gastric or gastroesophageal junction adenocarcinoma through histological or cytological examination.
- Inability to Receive Treatment: Patients who are unable to receive immune checkpoint inhibitors or SOX chemotherapy.
- Inability to Comply with Follow-up: Patients who are unable to adhere to the predetermined clinical follow-up schedule.
- Inability to Accept Study Protocol: Patients who cannot accept the treatment regimen specified in the study protocol.
- Inability to Provide Efficacy Assessment: Patients who cannot undergo or provide designated efficacy assessment methods such as CT scans.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tislelizumab + SOX ChemotherapyThe intervention in this study involves the use of tislelizumab, a humanized IgG4 anti-PD-1 monoclonal antibody, in combination with the standard SOX chemotherapy regimen for postoperative adjuvant therapy in patients with stage III gastric or gastroesophageal junction adenocarcinoma who are ctDNA-MRD positive. Tislelizumab is administered at a dose of 200 mg intravenously every 3 weeks for a total duration of 1 year, alongside 6-8 cycles of SOX chemotherapy. The SOX regimen includes oxaliplatin (130 mg/m² intravenously every 3 weeks) and tegafur, with the dose of tegafur determined based on body surface area and administered orally twice daily for 14 days every 3 weeks. | Drug | Tislelizumab + SOX Chemotherapy |
| SOX ChemotherapyThe control group will receive standard SOX chemotherapy alone, serving as an active comparator to evaluate the incremental benefit of adding tislelizumab. This design ensures a rigorous comparison while maintaining alignment with current standard-of-care practices. | Drug | SOX Chemotherapy Alone |
Primary outcome
disease-free survival (DFS)
Time frame: 1 year
1 secondary outcome
overall survival(OS)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tislelizumab + SOX Chemotherapy and SOX Chemotherapy in people with Gastric Cancer Stage III, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (DFS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.